The U.S. Securities and Exchange Commission (SEC) has issued the final order concluding an action against Baxter International Inc. over the company’s use of accounting mechanisms to produce gains by manipulating foreign exchange transactions. While these activities are said to have been undertaken entirely at the behest of only two employees, the agreement will cost Baxter $18 million and serves as a cautionary tale about a lack of supervision of employees charged with managing company funds.
Brainstorm Cell Therapeutics Inc.’s Nurown got a thumbs down from the U.S. FDA’s Cellular, Tissue and Gene Therapies Advisory Committee Sept. 27, as the committee voted 1-17, with one abstention, that the data presented demonstrated substantial evidence of effectiveness for treatment of mild to moderate amyotrophic lateral sclerosis.
The NDA for the formerly named Nyxol is now an open and shut case for Ocuphire Pharma Inc. and Viatris Inc. The U.S. FDA has approved Ryzumvi (phentolamine ophthalmic solution) for treating pharmacologically induced mydriasis, better known as dilating the pupil. Ryzumvi, a small-molecule eye drop, reduces the pupil’s diameter after it is dilated with adrenergic agonists such as phenylephrine or parasympatholytic agents such as tropicamide. The treatment reduces pupil size by acting on the iris dilator muscle.
Ossdsign AB will abandon its 3D-printed cranial reconstructive implant business to focus on U.S. sales of its Ossdsign Catalyst, an off-the-shelf nanosynthetic bone graft that offers gross margins of 90% or better. The new strategy sharply reduces the capital required before the company projects achieving a cash-flow positive position.
The U.S. FDA recently convened an advisory hearing to discuss whether three in vitro diagnostics should be reclassified from class III to class II, including tests for the pathogens responsible for Hepatitis B and tuberculosis. The panel agreed that all three of the test types should be reshuffled to the lower-risk class II category, suggesting that test developers now have an opportunity to jump into a market with lower-cost tests that won’t need expensive and drawn-out clinical studies to obtain the FDA’s seal of approval.
Zig Therapeutics Inc. reported on new patented systems and methods for the remote diagnosis and treatment of a bacterial infection in individuals with chronic respiratory diseases experiencing acute respiratory exacerbations using automated color vision sputum analysis.
Enovis Corp. has agreed to acquire Limacorporate S.p.A. (Lima) from EQT Capital for €800 million (US$847 million) as part of its growth strategy that will see it achieve $2 billion in revenues by 2024. The transaction includes €700 million in cash and €100 million in shares of Enovis common stock, expected to be issued within 18 months after closing.
Femasys Inc. received U.S. FDA 510(k) clearance for Femaseed, an infertility treatment that delivers sperm directly to the fallopian tubes. Less invasive and more straightforward than in vitro fertilization, the procedure offers what the company said is a new and more affordable alternative to family building for couples encountering fertility issues.
Patent challenges for radiotherapy equipment might not make the splash that in vitro diagnostic patents have, but Elekta AB and Zap Surgical Inc., have been locked in a dispute over an Elekta patent for the past four years.
The Consolidated Appropriations Act of 2023 covered a lot of budget terrain for the U.S. federal government, but Section 3305 was unusual for this type of bill in that it called on the FDA to require cybersecurity features as a part of the Quality System Regulation (QSR).
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